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- Medical Device Consulting, 60+ Company Experience:
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Medical Device Consulting and Resource Periodicals

regulatory consultant
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Medical Device Strategist, Entrepreneur, Inventor, Advisor, and Sculptor

  • Julia S. Rasor is a medical device consultant with both broad and deep multifunctional expertise;
  • Uses tools developed from a 60-company experience repeatedly proven effective for cost-effective problem solving: 'Rasor Resource Newsletter' shares these valuable proven tools with Medical Device Executives;
  • Methods have repeatedly proven effective in putting companies on the 'Fast Track';
    • Solving business, clinical, and regulatory hurdles
    • Innovating
    • Identifying and designing around pitfalls
    • Expediting product clearance
    • Optimizing the revenue ramp
    • Obtaining funding
    • Meeting BOD milestones
  • Serial entrepreneur/start-up CEO;
  • Adviser to start-up CEOs;
  • Inventor of a $100M/year revenue medical product, first ultrasonic contrast agent;
  • Author of over 20 White Papers yielding increased sales, venture funding, and FDA acceptance of proposed approaches;
  • Speaker at numerous universities and industry conferences;
  • Track record of 100% success with FDA;
  • Julia is also a figurative sculptor see RasorsSculptures.com.
    Facebook   View Julia S. Rasor's LinkedIn profile 

Julia S. Rasor
Figurative Sculptor, Commissions
RasorsSculptures.com
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Consulting Services

Business/ Management

  • Turnaround, Troubleshooting
  • Fundraising Assistance, Venture Capital, Angel
  • Opportunity Assessment, Due Diligence
  • Interim Executive Management, CXO
    • Chief Executive Officer (CEO)
    • Chief Science Officer (CSO)
    • Chief Strategy Officer (CSO)
  • Prudent Cash Management Strategy
  • Cross-Functional Big Picture Strategy
  • Entrepreneur, Founder, Start-up CEO
  • Board of Directors (BOD)
  • Business Model
  • Market Research, Product Line-up
  • Bass Diffusion Modeling of Revenue Forecast
  • Customer Research, Surveys
  • Competitor Research
  • Business Development
  • Marketing, Increasing Sales
  • Project Management (PM)
  • Subcontracting/Subcontractor

Clinical/ Technical

  • Scientific Advisory Board (SAB)
  • Clinical Research Organization (CRO)
  • Research and Development (R&D)
  • Intellectual property (IP), Patents
  • Clinical Study Design, Data Analysis
  • Clinical Study Monitoring
  • Preclinical Study Design, Data Analysis
  • In Vitro Models
  • In Vivo Models
  • Data and Statistics, Bayesian and Frequentist
  • Medical Writing, White Papers, Publications

Regulatory

  • IDE, 510(k), PMA, ANDA, NDA
  • Liaison with FDA
  • Responses to FDA Questions
  • Gaining FDA agreement to new regulatory paths
  • Gaining FDA agreement to optimal endpoints
  • Global Regulatory Strategies

Quality

  • CAPA's
  • Quality System Regulations
  • IS0 13485
  • QMS Audits
  • European CE Marking
  • Technical Files
  • STED
  • Japan PAL
  • China SFDA
  • Sterilization
  • Canadian Licenses
  • Internal and Supplier Audits
  • FDA Mock Audits
  • 483 & Warning Letter Responses
  • ISO 14971
  • Validations
  • Design Control
  • Risk Analysis & Management
  • DHF Development
  • CMDCAS
  • GMP
  • Resolving Consent Decrees
  • Drug Listing, Registration, and Master Files

Resource Periodicals

Rasor Resource Newsletters

Over the years we have discovered, and colleagues have shared, a plethora of useful tools we have utilized to assist clients, leading to results of pivotal importance. They can be downloaded for one dollar each in the Rasor Resource Newsletter section below.

 

Rasor Resource Industry Information

Timely information, events, and the principal's talk presentation and publication materials, that may be of interest to those in the medical device industry and to entrepreneurs, are available for download for one dollar each.